EFSA Journal最新文献

{"title":"Surveillance of West Nile virus infections in humans and animals in Europe, monthly report – data submitted up to 5 August 2026","authors":"European Centre for Disease Prevention and Control (ECDC), European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2026.10304","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10304","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Findings from human surveillance</h3>\u0000 \u0000 <p>In 2026, and as at 5 August, seven countries in Europe have reported 245 locally acquired<sup>1</sup> human cases of West Nile Virus (WNV) infection. The earliest and latest date of onset were on 12 May 2026 and 1 August 2026, respectively. Locally acquired cases have been reported by <b>Italy</b> (139 cases), <b>Greece</b> (65, of which four with unknown place of infection), <b>Spain</b> (17 cases), <b>North Macedonia</b> (13 cases), <b>Romania</b> (six cases), <b>France</b> (four cases) and <b>Germany</b> (one case). In Europe, 12 deaths have been reported by <b>Greece</b> (six deaths), <b>Italy</b> (five deaths) and <b>Romania</b> (one death).</p>\u0000 \u0000 <p>The number of human cases reported so far (245 cases) is below the average for the corresponding period over the past decade (403 cases). However, reporting delays may result in an under-estimation of the current burden, as the 2026 data remain provisional, whereas the ten-year average is based on consolidated data from previous years. In addition, this ten-year average is influenced by several particularly intense WNV transmission seasons, notably in 2018 (1065 cases reported up to the corresponding week), 2022 (781 cases) and 2024 (654 cases). To date, most cases have been reported in <b>Italy</b> (139 cases) and <b>Greece</b> (65 cases). Although the number of cases reported in Italy is lower than during the same period in 2025 (168 cases), it remains the most affected country in Europe in 2026. <b>Greece</b> has reported more cases in 2026 than during the same period in 2025 (65 cases compared with 26 cases). WNV circulation is currently most intense in the Attica NUTS 2 region (48 cases), with Anatoliki Attiki (East Attica, 34 cases) and Voreios Tomeas Athinon (North Athens, seven cases) most affected.</p>\u0000 \u0000 <p>As at 5 August 2026, locally acquired human cases of WNV infection had been reported in 58 NUTS 3 regions across seven countries. This is higher than at the same point in 2025, when cases were reported in 40 NUTS 3 regions across six countries. However, the geographical spread observed so far in 2026 remains well below the final extent recorded in recent seasons: by the end of 2025, affected regions numbered 160 and in 2024 there were 218. The 2024 season remains the largest WNV season on record in terms of geographical spread.</p>\u0000 \u0000 <p>This year, six regions reported locally acquired human cases of WNV infection for the first time ever: <b>France</b> in Pyrénées-Orientales (FRJ15); <b>Germany</b> in Rhein-Pfalz-Kreis (DEB3I); <b>Italy</b> in Campobasso (ITF22) and Viterbo (ITI41); <b>North Macedonia</b> in Pelagoniski (MK005) and Vardarski (MK001). Similar to previous years, most cases were reported among males aged 65 years and above. Most cases were hospitalised (72%) and pr","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 8","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10304","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148783952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety assessment of the substance 1,3-benzenedicarboxamide, 5-[[[cis-4-(1,1-dimethylethyl)cyclohexyl]carbonyl]amino]-N1,N3-bis[cis-4-(1-methylethyl)cyclohexyl]- for use in food contact materials","authors":"EFSA Panel on Food Contact Materials (FCM),&nbsp;Claude Lambré,&nbsp;Riccardo Crebelli,&nbsp;Maria João da Silva,&nbsp;Konrad Grob,&nbsp;Ester Heath,&nbsp;Evgenia Lampi,&nbsp;Maria Rosaria Milana,&nbsp;Marja Pronk,&nbsp;Mario Ščetar,&nbsp;Georgios Theodoridis,&nbsp;Els Van Hoeck,&nbsp;Nadia Waegeneers,&nbsp;Ronan Cariou,&nbsp;Laurence Castle,&nbsp;Emma Di Consiglio,&nbsp;Roland Franz,&nbsp;Eric Barthélémy,&nbsp;Remigio Marano,&nbsp;Gilles Rivière","doi":"10.2903/j.efsa.2026.10292","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10292","url":null,"abstract":"<p>The EFSA Panel on Food Contact Materials assessed the safety of the 1,3-benzenedicarboxamide, 5-[[[<i>cis</i>-4-(1,1-dimethylethyl)cyclohexyl]carbonyl]amino]-N1,N3-bis[<i>cis</i>-4-(1-methylethyl)cyclohexyl]-, to be used as a clarifying agent in polypropylene at up to 0.08% w/w. The final articles are intended for contact with all types of food except foods containing more than 10% ethanol, infant formula or mineral water intended to be used to reconstitute infant formula. They are intended for long-term storage at room temperature and below, including hot fill and heating conditions. The migration of the substance was below the limit of quantification of 0.05 mg/kg food in 10% ethanol, with values estimated up to 0.031 mg/kg in olive oil. The migration of the trans isomers can be estimated up to 0.0006 mg/kg food. The total mass transfer of all impurities was individually below 0.05 mg/kg food. The Panel excluded genotoxicity concerns for the substance based on in vitro studies. Trans isomers and relevant impurities were assessed using in silico and literature data and did not raise concerns for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumer if it is used at up to 0.08% w/w in polypropylene homo- and co-polymers, and the manufactured materials and articles are: (i) for single and repeated use, in contact up to and above 6 months at room temperature and below, including hot-fill conditions and/or heating up to 70°C ≤ <i>T</i> ≤ 100°C for maximum <i>t</i> = 120/2^((<i>T</i> − 70)/10) min; and (ii) are used in contact with all types of food, excluding beverages with an ethanol content above 10%, infant formula, including reconstituted infant formula and human milk.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 8","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10292","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148753495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and efficacy of a feed additive consisting of l-isoleucine produced with Corynebacterium glutamicum CGMCC 32505 for all animal species (Xinjiang Fufeng Biotechnologies Co., Ltd)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Giovanna Martelli,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Katerina Theodoridou,&nbsp;Montserrat Anguita,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Tarrés-Call,&nbsp;Yolanda García-Cazorla","doi":"10.2903/j.efsa.2026.10291","DOIUrl":"10.2903/j.efsa.2026.10291","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of <span>l</span>-isoleucine produced by fermentation with <i>Corynebacterium glutamicum</i> CGMCC 32505 as a nutritional additive in feed or water for drinking for all animal species and categories. The production strain is genetically modified. None of the genetic modifications raised a safety concern. Viable cells or DNA of the production strain were not detected in the final product. The use of <span>l</span>-isoleucine produced with <i>C. glutamicum</i> CGMCC 32505 in feed was considered safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs. The FEEDAP Panel had concerns on the use of amino acids in water for drinking. The use of <span>l</span>-isoleucine (≥ 98.0%) produced with <i>C. glutamicum</i> CGMCC 32505 in animal nutrition was considered safe for the consumers and the environment. Regarding the safety for the user, owing to the lack of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes and to be a potential skin sensitiser. The additive was regarded as an effective source of the amino acid <span>l</span>-isoleucine for all non-ruminant species. To be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 8","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13454949/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148705801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of confirmatory data following the Article 12 MRL review and setting of an import tolerance for fluopyram in limes","authors":"European Food Safety Authority (EFSA),&nbsp;Giulia Bellisai,&nbsp;Giovanni Bernasconi,&nbsp;Irene Castellan,&nbsp;Monica del Aguila,&nbsp;Lucien Ferreira,&nbsp;Renata Leuschner,&nbsp;Andrea Mioč,&nbsp;Marta Szot,&nbsp;Manuela Tiramani,&nbsp;Alessia Verani","doi":"10.2903/j.efsa.2026.10279","DOIUrl":"10.2903/j.efsa.2026.10279","url":null,"abstract":"<p>The applicant Bayer AG Crop Science Division submitted a request to the competent national authority in Germany to evaluate the confirmatory data for the active substance fluopyram that were identified in the maximum residue levels (MRLs) review under Article 12 of Regulation (EC) No 396/2005. Within the same submission, the applicant also requested, in accordance with Article 6 of Regulation (EC) No 396/2005, to set an import tolerance for fluopyram in limes. To address the Article 12 data gaps, new residue trials on lemons, tomatoes, melons, escaroles, land cresses and leeks were submitted. The additional trials on grapefruits and oranges were included as well although not required. No new residue trials were submitted to support tentative MRLs for bananas, Chinese cabbage/pe-tsai, spinaches chards/beet leaves and globe artichokes. The new information provided, together with the assessment of alternative GAPs, enabled the derivation of revised MRLs. In the result of the assessment, the tentative MRLs were confirmed for grapefruits, oranges, lemons, mandarins, bananas and tomatoes. Moreover, lower MRLs were derived for spring onions, melons and watermelons, globe artichokes and leeks, while higher MRLs were derived for escaroles, land cresses and red mustards. In the absence of supporting data, and in line with the rotational crop assessment performed in the MRL review, an MRL of 0.15 mg/kg remains supported for Chinese cabbages/pe-tsai, spinaches and chards/beet leaves. The available residue data enabled the derivation, by extrapolation, of an import tolerance MRL of 0.9 mg/kg for limes. A revision of the consumer risk assessment for fluopyram was performed, and a consumer concern was not identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 8","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13449036/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148688652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and efficacy of a feed additive consisting of sodium nitrite for pigs, bovines, poultry, sheep, goats, rabbits and horses (ADDCON Europe GmbH)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Giovanna Martelli,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Katerina Theodoridou,&nbsp;Montserrat Anguita,&nbsp;Jaume Galobart,&nbsp;Jordi Ortuño,&nbsp;Jordi Tarrés,&nbsp;Matteo L. Innocenti","doi":"10.2903/j.efsa.2026.10246","DOIUrl":"10.2903/j.efsa.2026.10246","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of sodium nitrite when used as a technological additive (functional group: silage additives) to improve the ensiling characteristics of all types of fresh plant material for pigs, bovines, poultry, sheep, goats, rabbits and horses, up to a maximum concentration of 900 mg sodium nitrite/kg fresh matter. The additive is specified to be used only in the form of premixtures. Based on the data provided, the Panel concluded that, since nitrite is a normal constituent of silage and the use of the additive would not result in a substantial change in the exposure of animals, sodium nitrite as a silage additive is considered safe for the target species, consumers and the environment. Regarding user safety, sodium nitrite should be considered an eye irritant. This conclusion would apply, in principle, to any preparation/premixture containing the additive. No conclusion could be drawn on the potential of sodium nitrite to be a skin irritant or skin sensitiser. In the absence of data, the Panel could not conclude on the efficacy of sodium nitrite alone as a silage additive. The use of sodium nitrite in combination with other substances has the potential to improve the production of silage made from all types of fresh plant material by enhancing the preservation of nutrients and to improve the aerobic stability of silage made from easy-to-ensile fresh plant materials.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 8","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13449020/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148688688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of the feed additive consisting of lasalocid A sodium (Avatec® 150G) for turkeys, pheasants, guinea fowl, quails and partridges except laying birds thereof for the renewal of its authorisation (Zoetis Belgium SA)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Giovanna Martelli,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Katerina Theodoridou,&nbsp;Pier Sandro Cocconcelli,&nbsp;Jürgen Gropp,&nbsp;Guido Rychen,&nbsp;Ivana Teodorivic,&nbsp;Jaume Galobart,&nbsp;Fabiola Pizzo,&nbsp;Maria Vittoria Vettori,&nbsp;Orsolya Holczknecht,&nbsp;Elisa Petenatti,&nbsp;Alberto Navarro-Villa","doi":"10.2903/j.efsa.2026.10247","DOIUrl":"10.2903/j.efsa.2026.10247","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lasalocid A sodium (Avatec® 150G) as a coccidiostat for turkeys, pheasants, guinea fowl, quails and partridges. The additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel was not in a position to conclude on the safety of the additive for the target species. The use of lasalocid A sodium at the highest proposed level of 125 mg/kg complete feed for turkeys up to 16 weeks of life and in growing pheasants, partridges, quails and guinea fowl remains safe for the consumer under the current conditions of the authorisation. The proposed reduction of the withdrawal time to 3 days is considered safe for the consumer. The existing maximum residue levels (MRLs) for poultry tissues ensure consumer safety. The additive is irritant to the skin and eye and the respiratory tract, but it is not a dermal sensitiser. Exposure of the users by any route is considered a risk. The use of the additive at the proposed conditions of use does not pose a risk for the terrestrial and aquatic compartments nor to sediment. No concern for groundwater is expected. The additive is unlikely to bioaccumulate and the risk for secondary poisoning is considered low. Lasalocid A sodium from Avatec® 150G has the potential to control coccidiosis in turkeys for fattening, turkeys reared for reproduction and pheasants at the minimum use level of 75 mg/kg complete feed. The data provided do not allow the Panel to conclude on the coccidiostatic effect of the additive in guinea fowl, quails and partridges.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 8","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13449025/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148697210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of a feed additive consisting of montmorillonite-illite mixed layer clay mineral (1g557) for all animal species for the renewal of its authorisation (FIM Biotech GmbH)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Giovanna Martelli,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Katerina Theodoridou,&nbsp;Jaume Galobart,&nbsp;Maria Vittoria Vettori,&nbsp;Orsolya Holczknecht,&nbsp;Fabiola Pizzo,&nbsp;Piera Valeri","doi":"10.2903/j.efsa.2026.10244","DOIUrl":"10.2903/j.efsa.2026.10244","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the renewal of montmorillonite-illite mixed layer clay mineral as a technological feed additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel cannot conclude whether the additive montmorillonite-illite mixed layer clay mineral remains safe for the target species under the current conditions of the authorisation. The Panel also concludes that the use of the additive in animal nutrition remains safe for the consumer and for the environment under the current conditions of the authorisation. The additive should be considered as a skin and respiratory sensitiser. In absence of data, the FEEDAP Panel is not in the position to conclude on the eye irritation of the additive. Exposure of users by any route is considered a risk and should be minimised. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 8","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13445242/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148683889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of genetically modified RF3 Canola Quality (CQ) Brassica juncea (application EFSA-GMO-NL-2019-158)","authors":"EFSA Panel on Genetically Modified Organisms (GMO),&nbsp;Josep Casacuberta,&nbsp;Francisco Barro,&nbsp;Albert Braeuning,&nbsp;Ruud de Maagd,&nbsp;Michelle M. Epstein,&nbsp;Thomas Frenzel,&nbsp;Jean-Luc Gallois,&nbsp;Frits Koning,&nbsp;Antoine Messéan,&nbsp;F. Javier Moreno,&nbsp;Fabien Nogué,&nbsp;Giovanni Savoini,&nbsp;Alan H. Schulman,&nbsp;Christoph Tebbe,&nbsp;Eve Veromann,&nbsp;Michele Ardizzone,&nbsp;Giacomo De Sanctis,&nbsp;Antonio Fernandez Dumont,&nbsp;Arianna Ferrari,&nbsp;Andrea Gennaro,&nbsp;José Ángel Gómez Ruiz,&nbsp;Tilemachos Goumperis,&nbsp;Dafni Maria Kagkli,&nbsp;Paolo Lenzi,&nbsp;Aleksandra Lewandowska,&nbsp;Silvia Federici,&nbsp;Ana M. Camargo,&nbsp;Franco Maria Neri,&nbsp;Nikoletta Papadopoulou,&nbsp;Tommaso Raffaello","doi":"10.2903/j.efsa.2026.10178","DOIUrl":"10.2903/j.efsa.2026.10178","url":null,"abstract":"<p>Genetically modified RF3 Canola Quality (CQ) <i>Brassica juncea</i> was developed to confer tolerance to glufosinate-based herbicides and to restore fertility in Barnase-expressing plants. The RF3 event was originally developed in <i>Brassica napus</i> and has previously been assessed by EFSA in application EFSA-GMO-RX-MS8-RF3. The GMO Panel assessment of the molecular characterisation data and bioinformatics analyses did not raise issues that would require specific food and feed safety assessments. None of the identified differences in the agronomic, phenotypic and compositional characteristics tested between RF3 CQ <i>B. juncea</i> and its comparator need further assessment, except for yield, crude fat, aspartic acid and behenic acid (C22:0), which underwent additional evaluation and were found to not raise any environmental impact and safety or nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the PAT/<i>bar</i> and Barstar proteins as expressed in RF3 CQ <i>B. juncea</i> and finds no evidence that the genetic modification would change the overall allergenicity of RF3 CQ <i>B. juncea</i>. In the context of this application, the consumption of food and feed from RF3 CQ <i>B. juncea</i> does not represent a nutritional concern in humans and animals. The GMO Panel concludes that RF3 CQ <i>B. juncea</i> is as safe as the comparator and CQ non-GM <i>B. juncea</i> varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of release of RF3 CQ <i>B. juncea</i> material, including viable seeds, into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of RF3 CQ <i>B. juncea</i>. The GMO Panel concludes that RF3 CQ <i>B. juncea</i> is as safe as its comparator and the tested CQ non-GM <i>B. juncea</i> varieties with respect to potential effects on human and animal health and the environment.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 8","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13435101/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148673076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and efficacy of a feed additive consisting of nicarbazin (NICACOX®) for chickens for fattening and chickens reared for laying (Huvepharma N.V.)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Giovanna Martelli,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Katerina Theodoridou,&nbsp;Georges Bories,&nbsp;Paul Brantom,&nbsp;Jürgen Gropp,&nbsp;Guido Rychen,&nbsp;Luca Tosti,&nbsp;Ruud Woutersen,&nbsp;Jaume Galobart,&nbsp;Fabiola Pizzo,&nbsp;Alberto Navarro-Villa,&nbsp;Maria Vittoria Vettori,&nbsp;José Cortiñas Abrahantes,&nbsp;Orsolya Holczknecht","doi":"10.2903/j.efsa.2026.10251","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10251","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of nicarbazin (NICACOX®) as a coccidiostat for chickens for fattening and chickens reared for laying. The FEEDAP Panel concluded that NICACOX® is safe for chickens for fattening and chickens reared for laying when used at concentrations up to 80 mg nicarbazin/kg complete feed during the first 21 days of life. The use of the additive under the proposed conditions (maximum use level of 80 mg/kg complete feed for 21 days) is considered safe for the consumer, provided that a withdrawal period of 5 days is ensured. Nicarbazin is not a skin nor eye irritant and is not a dermal sensitiser. In the absence of specific data on the final additive, the FEEDAP Panel cannot conclude on the safety of NICACOX® for the users. The use of nicarbazin (DNC and HDP) from NICACOX® in complete feed for chickens for fattening does not pose a risk for the terrestrial and aquatic compartments nor to sediment under the proposed condition of use. No concern for groundwater is expected, and no risk of secondary poisoning is identified. Nicarbazin from NICACOX®^, given at a level of 75 mg/kg complete feed for the first 21 days of life is effective in preventing coccidiosis of chickens for fattening and chickens reared for laying in the corresponding time period.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 8","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10251","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148652474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Scientific assessment of the 2024 post-market environmental monitoring report on the cultivation of genetically modified maize MON 810 in the EU","authors":"European Food Safety Authority (EFSA),&nbsp;Antoine Messéan,&nbsp;Yann Devos,&nbsp;Fernando Álvarez,&nbsp;Ana M. Camargo","doi":"10.2903/j.efsa.2026.10278","DOIUrl":"https://doi.org/10.2903/j.efsa.2026.10278","url":null,"abstract":"<p>At the request of the European Commission, EFSA assessed the 2024 post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810, which expresses the Cry1Ab protein. Using a weight-of-evidence approach and considering information provided by the consent holder and the Competent Authorities of Portugal and Spain, EFSA concluded that the PMEM report provides no evidence of unexpected adverse effects on human and animal health, or on the environment associated with the cultivation of maize MON 810 in 2024. Refuge compliance was generally high in Spain and fully achieved in Portugal. However, uncertainty remains in situations where clusters of small maize MON 810 fields may collectively exceed the 5-ha threshold requiring refuge implementation. No evidence of practical resistance to Cry1Ab was identified in European corn borer populations sampled in north-eastern Spain in 2024. Nevertheless, the consistently low Cry1Ab susceptibility observed in Mediterranean corn borer populations from this area between 2022 and 2024, together with unexpected field damage reported in Girona in 2021 as well as indications of resistance alleles detected in 2024, indicate that a decrease in susceptibility cannot be excluded. EFSA also considers that the current resistance monitoring strategy lacks sufficient sensitivity for the early detection of resistance evolution. General surveillance activities, including farmer questionnaires in Spain and annual literature searches, did not identify unanticipated adverse effects. However, uncertainty remains regarding the potential exposure of highly sensitive non-target Lepidoptera to maize MON 810 pollen due to the lack of implementation data on isolation distances toward protected habitats. EFSA also identified methodological and reporting shortcomings in both case-specific monitoring and general surveillance, while welcoming the continued efforts of the Competent Authorities of Spain to address data gaps and support refinement of monitoring and risk management measures. After more than two decades of cultivation without evidence of unexpected adverse environmental effects, EFSA considers that general surveillance could be streamlined to focus on two core elements: (1) a strengthened farmer complaint system, complemented where appropriate by existing plant health and pest monitoring networks; and (2) transparent and comprehensive annual literature searches.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"24 8","pages":""},"PeriodicalIF":3.8,"publicationDate":"2026-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2026.10278","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148652473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}